Critical IllnessNCT04507451
Respiratory Muscle Training in ICU Patients
A study testing inspiratory and expiratory muscle training and inspiratory and expiratory exercises in people with Critical Illness and Inspiratory Muscle Strength, run by University of Liege at 1 site in Belgium.
Trial summary
Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Critical Illness, Inspiratory Muscle Strength, Mechanical Ventilation
- What is being tested?
- inspiratory and expiratory muscle training and inspiratory and expiratory exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2020to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient from mechanical ventilation after at least 24 hours of support
- collaborative patient
Who cannot join
- confusion, mental disorder
- not french speaking
- pulmonary surgery in the past 12 months
- external ventricular drain
- previous pneumothorax or pneumothorax not drained
- rib fractures
Show all 10Show fewer
- alveolar hemorrhage
- hemodynamic instability
- labial occlusion impossible (face burn, facial paralysis)
- patient refusal
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Liège
Liège, 4000
Anne-Françoise Rousseau, PhD, +3243667495, afrousseau@chuliege.be
About this study
Official title: Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation
Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.
- Conditions
- Critical Illness, Inspiratory Muscle Strength, Mechanical Ventilation, Respiratory Muscle Training
- Being tested
- inspiratory and expiratory muscle training, inspiratory and expiratory exercises
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory and expiratory muscle trainingProcedure or surgery
inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water
inspiratory and expiratory exercisesProcedure or surgery
inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level
| Study group | Role | What they receive |
|---|---|---|
| Trained group | Experimental | Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week.
Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths
Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge Receives: Procedure: inspiratory and expiratory muscle training |
| Untrained group | Placebo comparator | Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week.
Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm)
Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge Receives: Procedure: inspiratory and expiratory exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in inspiratory muscle strength
measurement of maximal inspiratory pressure
Measured: between 7 to 15 days after ICU discharge (compared to ICU discharge)
change in inspiratory muscle strength
measurement of maximal inspiratory pressure
Measured: 1 month after ICU discharge (compared to ICU discharge)
Secondary outcomes (6)
change in expiratory muscle strength
measurement of maximal expiratory pressure
Measured: between 7 to 15 days after ICU discharge (compared to ICU discharge)
change in expiratory muscle strength
measurement of maximal expiratory pressure
Measured: 1 month after ICU discharge (compared to ICU discharge)
respiratory infections
number of respiratory infections requiring antibiotics after ICU discharge
Measured: 1 month after ICU discharge
change in dyspnea perception
assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea)
Measured: 1 month after ICU discharge (compared to hospital discharge)
impact of dyspnea on physical activities
assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)
Measured: between 7 to 15 days after ICU discharge
impact of dyspnea on physical activities
assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing)
Measured: 1 month after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507451
- Sponsor's protocol ID
- RESP-USI
- Status last verified
- Nov 2020
- First submitted
- 1 Aug 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04507451
- Acronym / sponsor ID
- RESP-USI
- Conditions
- Critical Illness, Inspiratory Muscle Strength, Mechanical Ventilation, Respiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trained group | Experimental | Procedure: inspiratory and expiratory muscle trainingPatients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week. Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge |
| Untrained group | Placebo comparator | Procedure: inspiratory and expiratory exercisesPatients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week. Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm) Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient from mechanical ventilation after at least 24 hours of support
- collaborative patient
Key exclusion criteria (10 listed)
- confusion, mental disorder
- not french speaking
- pulmonary surgery in the past 12 months
- external ventricular drain
- previous pneumothorax or pneumothorax not drained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory and expiratory muscle traininginspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water | Procedure or surgery | Trained group |
| inspiratory and expiratory exercisesinspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level | Procedure or surgery | Untrained group |
Primary outcome
change in inspiratory muscle strength
Time frame: between 7 to 15 days after ICU discharge (compared to ICU discharge)
measurement of maximal inspiratory pressure
change in inspiratory muscle strength
Time frame: 1 month after ICU discharge (compared to ICU discharge)
measurement of maximal inspiratory pressure
6 secondary outcomes
change in expiratory muscle strength
Time frame: between 7 to 15 days after ICU discharge (compared to ICU discharge)
change in expiratory muscle strength
Time frame: 1 month after ICU discharge (compared to ICU discharge)
respiratory infections
Time frame: 1 month after ICU discharge
change in dyspnea perception
Time frame: 1 month after ICU discharge (compared to hospital discharge)
impact of dyspnea on physical activities
Time frame: between 7 to 15 days after ICU discharge
impact of dyspnea on physical activities
Time frame: 1 month after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory and expiratory muscle training and inspiratory and expiratory exercises in people with Critical Illness and Inspiratory Muscle Strength, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Françoise Rousseau, MD, PhD (+3243667495, afrousseau@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in inspiratory muscle strength (time frame: between 7 to 15 days after ICU discharge (compared to ICU discharge)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.